FDA Registration
Active
🇺🇸 United States
AtriCure cryoICE cryo-ablation probe (CRYO2), AtriCure cryoICE cryoSPHERE Cryoablation System (CryoS/S-L)
Reg #: 3011706110
·
FEI: 3011706110
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ATRICURE, INC.
- Registration Number
- 3011706110
- FEI Number
- 3011706110
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7555 Innovation Way
- City
- Mason
- State
- OH
- ZIP
- 45040
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200697
Owner / Operator
- Firm Name
- ATRICURE, INC.
- Operator Number
- 9045049
- Address
- 7555 Innovation Way, --
- City
- Mason
- State
- OH
- Postal Code
- 45040
- Country
- US
- Correspondent
- John S Ehlert
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Surgical, Cryogenic | GXH | Class 2 | Neurology | No | 2021-01-05 |
Proprietary Names
AtriCure cryoICE cryo-ablation probe (CRYO2), AtriCure cryoICE cryoSPHERE Cryoablation System (CryoS/S-L)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device